IOM and COI: Painful Disclosures?

by John Fauber John Fauber,Reporter, Milwaukee Journal Sentinel/MedPage Today
June 25, 2014

When faced with intense criticism for her agency's approval of the powerful narcotic painkiller Zohydro, U.S. Food and Drug Administration Commissioner Margaret Hamburg turned to a sobering statistic: 100 million Americans are suffering from severe chronic pain.

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For a pdf that describes the conflicts of interest for nine IOM panel members, click here

The 100 million figure has become a staple in the ongoing debate over the use of narcotic painkillers. It is cited in news stories, by medical organizations and by drug companies seeking approval for new opioid therapies. When Hamburg spoke in April at a prescription drug conference, she noted it means debilitating pain affects more people than heart disease, cancer and diabetes combined.

But that number is exaggerated and misleading, according to pain specialists familiar with how it was derived.

A Journal Sentinel/MedPage Today investigation found that nine of the 19 experts on the IOM panel that produced that report had connections to companies that manufacture narcotic painkillers at the time or in the 3 years prior to their work on the report.

Some were officers or board members of groups that received opioid company funding, others were drug-company consultants or were paid for educational programs funded by companies that make pain drugs.

In addition, panel chairman Philip Pizzo, MD, was dean of the medical school at Stanford University when he chaired the panel, a school, which received educational grants and research funding from companies that make pain treatments.

Yet none of those financial links were disclosed in 2011 when the IOM issued its 364-page report.

That runs counter to the institute's own recommendations to the medical world, which say disclosure of conflicts of interest are "essential."

Catherine DeAngelis, MD, MPH, an IOM member and the former editor of JAMA, took it one step further saying the pain organization board members and officers should have excluded themselves from serving on the panel.

"It's a conflict," she said.

The institute's report devotes only a few pages to opioids, but it warns against efforts to restrict their use.

Indeed, six of the IOM panel members have been officers or board members of advocacy groups that were named in a 2012 U.S. Senate Committee on Finance investigation into the links. A seventh panel member co-founded another organization that is the subject of a separate investigation launched in February by two U.S. senators.

In that case, the group collected as much as $35,000 each from various drug companies and arranged private meetings at expensive hotels that were attended by drug executives, FDA officials and academics who discussed developing new pain treatments, the Journal Sentinel and MedPage Today reported last October.

But there has been little scrutiny of the 100 million figure -- one that is the equivalent of 40 percent of the nation's adult population. In recent months, it has been criticized as misleading by a researcher on whose study it was based and another who served as a reviewer of the report.

That request grew out of 2008 and 2009 Senate and House bills that asked the institute to examine pain issues. The measures were sponsored by lawmakers who have received hundreds of thousands of dollars from companies that make opioids and other pain treatments.

They were lobbied for by companies that make pain treatments and supported by pain organizations that get opioid industry funding and, in turn, got several of their members to serve on the pain panel.

In 2010, legislation authorizing the report was rolled into the Patient Protection and Affordable Care Act -- better known as the ACA or Obamacare. The law required the federal government to enter into an agreement with the institute "to increase the recognition of pain as a significant public health problem in the United States."

A year before the action by Congress, the IOM had taken a strong stand in favor of disclosure of conflicts of interest in medicine.

"Society traditionally has placed great trust in physicians and researchers, granting them considerable leeway to regulate themselves," the IOM concluded in a 2009 report. "However, there is growing concern among lawmakers, government agencies and the public that extensive conflicts of interest in medicine require stronger measures."

However, in producing the pain report, the institute didn't follow its own advice about disclosing conflicts.

The Journal Sentinel/MedPage Today investigation revealed a series of links, starting with the panel's chairman -- Pizzo, the former dean of Stanford's medical school.

In January, 2010 -- 10 months before the pain panel began meeting -- Pfizer gave Stanford a $3 million, 3-year grant to fund medical education. Stanford said the grant came with no conditions and Pfizer would not be involved in developing the curriculum.

Pfizer makes several pain-related drugs. In addition, other companies that make pain treatments have provided thousand of dollars in research and other funding to Stanford, according to the ProPublica "Dollars for Docs" data base.

In an email and an interview, Pizzo defended his work and the committee members.

"At no point in the process or since have I ever felt that any of our committee members operated with anything other than integrity and commitment to an incredibly important national health issue -- pain in America," he wrote.

He said the Pfizer grant to Stanford was given for medical education and "was completely unlinked to any of the company's products."

"I did not review the Pfizer portfolio and was never influenced in any way by products that company was engaged with," he said. "That was irrelevant to the gift for medical education and clearly unrelated to the work of the IOM committee on which I served as chair."

In an interview, he said the institute took a rigorous approach to reviewing conflicts among members.

"It is up to them to determine what is to be disclosed," he said.

Jennifer Walsh, a spokeswoman for the IOM, said under its disclosure policy, created in 2003, the institute can obtain conflict of interest information from its experts that will be held in confidence. The IOM policy bans release of the disclosure statements without permission of the expert.

Walsh said after members are screened in writing for conflicts there is a group discussion about the conflicts at the first committee meeting.

"It's hard to rationalize why they would not simply disclose all the potential conflicts on that panel," Carlat said.

In emails, several panel members said they complied with the institute's disclosure rules.

Dennis Turk, PhD, one of the IOM panel members, is the co-founder of a group, known as IMMPACT, that organized meetings that included FDA officials and representatives of drug companies that had paid up to $35,000 to attend.

Turk, a University of Washington researcher and editor-in-chief of The Clinical Journal of Pain, has worked as a consultant or received grants from several companies that market opioids and other pain drugs.

In an email, Turk said the institute has a formal policy for selecting members and handling conflicts of interest.

"To the best of my understanding I was in compliance with all of the IOM's procedures regarding disclosures of any potential conflicts of interest," he said.

Pizzo took exception with criticism that the 100 million figure lacked credibility.

"Let's not debate whether its 60 million or 80 million or 120 million," Pizzo said in an interview. "It is a significant problem. I totally disagree that we are not using numbers that are credible. This was our best estimate of the data."

Garbage In, Garbage Out?

The figure is problematic in part because it lumps together anyone who reports chronic pain, which is defined as lasting 3 to 6 months, from those with persistent but manageable back pain to those recovering from surgery or battling cancer. It includes those who may not even seek medical help, or treat their condition with over-the-counter products, with those who use prescription opioids.

In February, two experts connected with the pain report said the 100 million figure was exaggerated and misleading and they raised concerns about how it was being used. Their comments came at a meeting of pain experts held at the National Institutes of Health.

In a video of the meeting, Allan Basbaum, PhD, who reviewed the Institute of Medicine pain report, said he was stunned when he saw the 100 million figure.

"If we are concerned about the message we are sending, we shouldn't exaggerate the message because the eyeballs start to roll," said Basbaum, a pain expert and professor of anatomy at the University of California, San Francisco. "The message will be more powerful if people can believe it."

A moment later, pain expert Michael Von Korff, ScD, said the 100 million figure was derived from a research paper that he co-authored.

"Nobody asked me about it before they used it," said Von Korff, senior investigator with Group Health Research Institute in Seattle, said in the video.

While the 100 million represents about 40 percent of the adult population, Von Korff said only about 20 percent to 25 percent are substantially impaired by chronic pain and a smaller number -- about 10 percent to 15 percent -- have substantial work disability because of chronic pain.

"The 100 million number, I don't like it because I think it is a little misleading," he added.

In interviews both experts reiterated their comments, but stressed that pain still is a serious problem in America.

Von Korff said comparing the number of chronic pain sufferers to those with conditions such as cancer, heart disease and diabetes -- as the report did -- also was misleading.

"There are certainly 100 million people who experience back pain and arthritis," he said. "These are common problems. Is there 100 million who have chronic pain that is as consequential as cancer? No.

"You don't want to over medicalize something."

When FDA Commissioner Hamburg brought up the figure at a 3-day summit on America's opioid epidemic in April, she actually overstated the report itself.

She said concerns about opioid abuse must be balanced against "the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life."

But the pain report does not say apply the figure to "severe chronic pain." Rather, it says 100 million suffer from "common chronic pain."

In an email, Jeff Ventura, an FDA spokesman, said Hamburg intended to quote the information in the IOM report, that "chronic pain affects about 100 million American adults -- more than the total affected by heart disease, cancer, and diabetes combined."

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